Evaluation of plant protection products and active substances
The evaluation is performed by means of scientific studies carried out in accordance with specific rules and methods that allow a comparison of the results. This method guarantees solid, reliable studies These studies are carried out by laboratories that are accredited for this purpose and regularly audited. In addition, from 27 March 2021, it is possible for the EU administration itself to order studies to monitor the results.
European legislation defines which effects are to be examined, on which organisms and according to which methods and standards (the maximum allowed effects). This legislation is a compromise between what is feasible and what would be desirable. In order to exclude all possible risks, it would be necessary - from a scientific point of view - to examine all potential effects on all possible organisms, but this is not realistic. This would require unlimited time and resources, making it impossible to authorise any product. The legislation imposes an evaluation for a limited number of organisms, allowing the risks to other organisms to be inferred. No human studies are requested or accepted, but studies on mammals are used to assess the impact on humans. Likewise, studies on vertebrate animals should be avoided as much as possible.
During the authorisation procedure, we check whether the product complies with the legislation. Applications for authorisation must contain the data required by this legislation. No action can be taken if the product complies with the legislation. This provides the authorisation holder(the companies that submit the applications) with the legal certainty necessary to invest in studies, the construction of production facilities and the establishment of a supply chain. In exceptional circumstances, for example when doubt exists about certain effects, further information may be requested from the authorisation holder.
We evaluate each plant protection product separately, and therefore not the combined effect of several plant protection products. Due to the many possible combinations, it would be impossible to assess all potential effects. Moreover, there is as yet no scientifically validated method for this, except for a limited number of specific combinations.
In this evaluation, the effects of sowing treated seeds are also evaluated. This is because plant protection products that protect seeds against insects or moulds also find their way into the environment, with the risk of negative effects.
Specific protection measures are defined for each authorised product. These measures must be mentioned on the label of the marketed product.